MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site with Check Valve, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
FDA Recall Z-0701-2018 · Posted None
Recall StatusTerminated
Product CodeFPA
Date Initiated2017-11-10
Date Terminated2018-12-12
Product Quantity2,417/20-administration set cases
Reason for Recall
Particulate found on the Curlin spike.
Firm Action
The recalling firm began issuing letters via USPS certified mail with return receipt on 11/10/2017 and concluded on 11/13/2017. Updated letters dated 11/20/2017 were issued via certified mail to distributors and to medical facilities. The distributor letter emphasized their instructions to notify downstream accounts. The medical facility letter updated lot numbers.
The letter described the issue, risk to health, and actions the customer was to take. A response form was enclosed to report whether the customer has inventory they are not returning, that they no longer have inventory of the product, or the amount of product being returned for replacement. The form was to be returned via FAX or email.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.